| CTRI Number |
CTRI/2019/02/017439 [Registered on: 05/02/2019] Trial Registered Prospectively |
| Last Modified On: |
31/10/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to see how safe, tolerable & effective Dolutegravir drug is when taken with Tenofovir & Lamivudine inpatients with HIV-1 |
|
Scientific Title of Study
|
An Open-label, Multicenter, Prospective, Phase-IV, Interventional Study to Evaluate the Safety, Tolerability & Efficacy of Dolutegravir (50 mg once daily) in Treatment Naïve Adult Indian Subjects Infected with HIV-1, Eligible to Receive Dolutegravir with Tenofovir & Lamivudine |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MYL-DOL-4001 Version 1.0, Dated 04 Apr 2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonika Newar |
| Designation |
Senior Medical Monitor |
| Affiliation |
JSS Medical Research India Private Limited |
| Address |
Plot No.12/2, 6th Floor, Vatika Mindscapes, Tower B, , Sector 27 D
Faridabad
HARYANA
121003
India |
| Phone |
8800799887 |
| Fax |
129-6613520 |
| Email |
sonika.newar@jssresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shariq Anwar |
| Designation |
Head Operations |
| Affiliation |
JSS Medical Research India Private Limited |
| Address |
Plot No.12/2, 6th Floor, Vatika Mindscapes, Tower B, , Sector 27 D
Faridabad
HARYANA
121003
India |
| Phone |
9810979215 |
| Fax |
129-6613520 |
| Email |
shariq.anwar@jssresearch.com |
|
|
Source of Monetary or Material Support
|
| Mylan Laboratories Limited
Plot No. 564/A/22, Road No. 92,
Jubilee Hills, Hyderabad – 500 034.
Telangana, India.
|
|
|
Primary Sponsor
|
| Name |
Mylan Laboratories Limited |
| Address |
Plot No. 564/A/22, Road No. 92,
Jubilee Hills, Hyderabad – 500 034.
Telangana, India.
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 14 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr T Jayaprakash |
Anu Hospitals |
Kovelamudivari street, Suryaraopet, Vijayawada
Krishna
ANDHRA PRADESH |
9440668304
docjapee@rediffmail.com |
| Dr Surabhi Madan |
Care Institute of Medical Sciences (CIMS) Hospital |
Near Shukan Mall, Off Science City Road, Sola
Ahmadabad
GUJARAT |
9712971863
surabhi.madan@cimshospital.org |
| Dr Vinay Kulkarni |
Deenanath Mangeshkar Hospital |
Near Mhatre Bridge, Erandawne
Pune
MAHARASHTRA |
9822300532
vinay@prayaspune.org |
| Dr Abhishek Pande |
Government Medical College & Hospital |
Medical College Square Road, Nagpur-440003
Nagpur
MAHARASHTRA |
8793653698
drabhishekpande@yahoo.com |
| Dr Siddabathuni Nageswaramma |
Guntur Government General Hospital |
Opp Railway Station Road, Rail Pet,522001
Guntur
ANDHRA PRADESH |
9849143461
ravindranag@gmail.com |
| Dr Kartik Vikrambhai Patel |
Kanoria Hospital and Research Centre |
Near Indira bridge, Hansol-Gandhinagar Highway, Bhat, Gandhinagar
Gandhinagar
GUJARAT |
9879615645
drkartikpatel1980@gmail.com |
| Dr John T Ramapuram |
Kasturba Medical College Hospital |
Attavar, Mangalore-575001
Dakshina Kannada
KARNATAKA |
08242445858
john@ramapuram.net |
| Dr Dnyanesh Morkar |
KLES DR Prabhakar Kore Hospital |
Nehru Nagar
Belgaum
KARNATAKA |
7204703019
dnyaneshmorkar@rediffmail.com |
| Dr Milind Bhrushundi |
Lata Mangeshkar Multispecialty Hospital |
5, YMCA Complex, MaharajBagh Road, Sitabuldi,
Nagpur
MAHARASHTRA |
9860562640
bmili@yahoo.com |
| Dr S Anuradha |
Maulana Azad Medical College and Associated Lok Nayak, Govind Ballab Pant Hospital, |
Guru Nanak Eye Center, 2-Bahadur Shah Zafar Marg
New Delhi
DELHI |
9811184924
drsanuradha@gmail.com |
| Dr Dwijendra Prasad |
People Tree Hospitals Clinical Research |
People Tree Hospitals,2, tumkur Road, Goraguntepalya
Bangalore
KARNATAKA |
9986311918
dwpj100@yahoo.com |
| Dr Amit N Dravid |
Poona Hospital and Research Centre |
L.B Shastri Road, 27 Sadashiv Peth- 411030
Pune
MAHARASHTRA |
9975619766
ameet.dravid@gmail.com |
| Dr K Sunil Naik |
Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital |
Department of Medicine, Srikakulam- 532001
Srikakulam
ANDHRA PRADESH |
9440828299
rimsresearch@gmail.com |
| Dr Milind Kulkarni |
Sahyadri Super Specialty Hospital |
Survey no 185A, near MSCB Office, Nagar Road, Shastrinagar, Yerawada,
Pune
MAHARASHTRA |
9860312537
drmilindjivi@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 14 |
| Name of Committee |
Approval Status |
| Ethics Committee of CIMS Hospital |
Approved |
| Institutional Ethics Committe,Government Medical College & Hospital, Nagpure, |
Approved |
| Institutional Ethics Committee, Deenanath Mangeshkar Hospital. |
Approved |
| Institutional Ethics Committee, KLES DR Prabhakar Kore Hospital |
Approved |
| Institutional Ethics Committee, LMH |
Approved |
| Institutional Ethics Committee, Maulana Azad Medical College |
Approved |
| Institutional Ethics Committee, Poona hospital and research centre |
Approved |
| Institutional Ethics Committee, Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital |
Approved |
| Institutional Ethics committee,Guntur Medical college and govt. general hospital |
Approved |
| Institutional Ethics Committee-Anu Hospitals |
Approved |
| Kanoria Ethics Committee |
Approved |
| MAHE Ethics Committee, Kasturba Medical College Hospital |
Approved |
| People Tree Hospitals Ethics Committee |
Approved |
| Sahyadri hospital Ltd. Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B20-B20||Human immunodeficiency virus [HIV] disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dolutegravir (50 mg once daily) with Tenofovir & Lamivudine 300/300 mg |
Dose: 50 mg
Frequency: Once daily
Route of administration: Oral
Duration of treatment: 20 weeks |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female, age ≥ 18 years at the time of signing of an ICF.
2. Confirmed and documented HIV-1 infection, treatment naïve and eligible to receive Dolutegravir with Tenofovir and Lamivudine.
3. Screening ECG without clinically significant abnormalities.
4. Weight > 40 Kgs.
5. Willing and able to provide written informed consent and agreeable to comply with protocol requirement.
6. Subject has not been treated with any investigational drug or device within 30 days or 5 half-lives of investigational drug, whichever is longer, of the screening visit.
7. Males and females following adequate contraception
|
|
| ExclusionCriteria |
| Details |
1. Pregnant or nursing female.
2. Previous or current AIDS defining illness.
3. Any uncontrolled opportunistic infection or malignancy.
4. Inadequate neutrophil count and platelet count
5. Subjects with inadequate hemoglobin
6. Documented or known clinically-relevant drug or alcohol abuse
7. Subjects with renal and liver impairment
8. Subjects on medicinal products which are contraindicated to be used with Dolutegravir, Tenofovir and Lamivudine (other approved ARV drugs).
9. Subjects having arrhythmia, wherein administration of Dofetilide is required.
10. History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
11. History of a gastrointestinal disorder (or post-operative condition) that could interfere with the absorption of the study drug.
12. History of difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
13. Known hypersensitivity to the study investigational medicinal product, the metabolites, or formulation excipients, as applicable.
14. Subject is unable to follow study instructions and comply with the protocol in the opinion of the investigator.
15. Any other condition as per the physician’s discretion that would make the subjects ineligible for the study.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of adverse events |
throughout the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of subjects achieving plasma HIV-1 RNA 50 copies/mL in the treatment group |
At the end of the treatment |
| Change in CD4plus cell count from baseline |
At the end of the treatment |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
15/02/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is an Open-label, Multicenter, Prospective,
Phase-IV, Interventional Study to Evaluate the Safety, Tolerability & Efficacy
of Dolutegravir (50 mg once daily) in Treatment Naïve Adult Indian Subjects
Infected with HIV-1, Eligible to Receive Dolutegravir with Tenofovir &
Lamivudine.
The Primary
objective of the study is to assess the safety and tolerability of Dolutegravir
in adult Indian subjects infected with HIV-1. The Secondary objective of the
study is to assess the efficacy of Dolutegravir in adult Indian subjects
infected with HIV-1.
The primary
endpoint is the incidence of adverse events during the study and the secondary
endpoint is the Proportion of subjects achieving plasma HIV-1 RNA < 50
copies/mL in the treatment group at the end of treatment (Week 24) and change
in CD4+ cell count from baseline to the end of treatment (Week 24). |